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BACKGROUND In November 2001, the Food and Drug Administration (FDA) approved drotrecogin alfa (activated) (DrotAA) for adults who had severe sepsis and a high risk of death. The FDA required a study to evaluate the efficacy of DrotAA for adults who had severe sepsis and a low risk of death. METHODS We randomly assigned adult patients with severe sepsis(More)
BACKGROUND Despite the availability of potent antibiotics and intensive care, mortality rates from septic shock are 40-70%. We assessed the safety and efficacy of murine monoclonal antibody to human tumour necrosis factor alpha (TNF alpha MAb) in the treatment of septic shock. METHODS In a randomised, multicentre, double-blind, placebo-controlled clinical(More)
OBJECTIVE To evaluate the efficacy and safety of anti-tumor necrosis factor alpha monoclonal antibody (TNF-alpha MAb) in the treatment of patients with sepsis syndrome. DESIGN Randomized, prospective, multicenter, double-blind, placebo-controlled clinical trial. SETTING A total of 31 hospitals in the United States and Canada. PATIENTS There were 994(More)
OBJECTIVE To determine whether adding erythromycin to a gastric feeding regimen could render it as effective in meeting nutritional needs as transpyloric feeding. DESIGN Randomized, controlled study. SETTING University hospital medical, surgical, and neurologic care intensive care units. PATIENTS Critically ill patients, requiring a projected 96 hrs(More)
OBJECTIVE To test the effect of a novel bradykinin antagonist, deltibant (CP-0127), on survival, organ dysfunction, and other outcomes in patients with the systemic inflammatory response syndrome (SIRS) and presumed sepsis. DESIGN Multicenter, randomized, placebo-controlled, double-blind, parallel, dose-ranging trial. Follow-up for 28 days or until death.(More)
Acute kidney injury (AKI) is common in critically ill patients with severe sepsis (SS), and the predictors of AKI in this population have not been well characterized. The study group was the placebo group of the Prospective Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) data set. PROWESS is a prospective, randomized,(More)
OBJECTIVES To determine the safety and efficacy of recombinant thrombomodulin (ART-123) in patients with suspected sepsis-associated disseminated intravascular coagulation. DESIGN Phase 2b, international, multicenter, double-blind, randomized, placebo-controlled, parallel group, screening trial. SETTING Two hundred and thirty-three ICUs in 17 countries.(More)
BACKGROUND Unplanned extubation (self-extubation or accidental extubation) occurs commonly in mechanically ventilated patients, and many patients do not receive mechanical ventilation indefinitely. Unfortunately, weaning parameters are often unavailable in the setting of unplanned extubation, and it would be useful to define pre-extubation respiratory and(More)
Objectives: To determine the difference in aspiration rates between gastrically and transpylorically fed patients in the intensive care unit. Design: A prospective controlled study of critically ill patients randomized to receive either a gastrically placed feeding tube or a transpylorically placed feeding tube. Setting: University teaching hospital's(More)
OBJECTIVE To determine the therapeutic efficacy and safety of recombinant human interleukin-1 receptor antagonist (rhIL-1ra) in the treatment of patients with severe sepsis. DESIGN Prospective, randomized, double-blind, placebo-controlled, multicenter trial with a planned, midstudy, interim analysis. SETTING Ninety-one academic medical center intensive(More)